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Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative Management | Active Comparator |
| |
| Non-operative Management | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open reduction internal fixation | Procedure | treatment with open reduction and plates/screws |
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| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) | Range of Motion of the shoulder in terms of degrees of motion Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees) | at 3 months, 6 months, 12 months, and 24 months from initiation of treatment |
| SANE | "Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function | at 3 months, 6 months, 12 months, and 24 months following initiation of treatment |
| VAS | "VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured. | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention |
| ASES | The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome. | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention |
| EQ-5D-5L | The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Iovanel, MD | Contact | 401-651-8188 | iovanel.gregory@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wayne Chan, MD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01605 | United States |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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| intramedullary nail | Procedure | open reduction and intramedullary nail |
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| reverse total shoulder arthroplasty | Procedure | reverse total shoulder arthroplasty |
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| at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention |
| Brophy/Marx | The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active). | at baseline and subsequently at 12 months and 24 months after initiation of intervention |
| PROMIS Social | PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less. | at 3 months, 12 months, and 24 months following initiation of intervention |
| Radiographic Outcome | evidence of bony healing, nonunion, or malunion of the fracture on imaging | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention |
| Complication Rate | Rate of complications following initiation of management | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention |
| D013514 |
| Surgical Procedures, Operative |